510(k) · Cleared
Recalled · Class II · 2017Medhot Mti 2000 Thermal Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medhot Thermal Imaging, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Oct 19, 2006 after a 15-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 19, 2006
- Review
- 15 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK181716 InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health · 2019
- Descendant · 3 generations on · 1 of its ownK213650 ThermPix Thermovisual CameraUsa Therm, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK200999 Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK253911 Derma-2Neko Health AB · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171928Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017 · cites it directly6descendants
- K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health · 2019 · 2 generations on2descendants
- K213650ThermPix Thermovisual CameraUsa Therm, Inc. · 2022 · 3 generations on1descendant
- K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. · 2021 · 2 generations on1descendant
- K253911Derma-2Neko Health AB · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063047 | Medhot Mti 2000 Thermal Imaging System | Medhot Thermal Imaging, Inc. | 2006 | — |
| +1 | K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017 | — |
| +2 | K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019 | — |
| +3 | K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022 | — |
| +2 | K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021 | — |
| +3 | K253911 | Derma-2 | Neko Health AB | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LHQ device
- #1 K253911 Derma-2score 12.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Telethermographic camera Series A, E, P, and S Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171928 | Med-Hot Thermal Imaging Systems | 2017 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2017 | Class II | Z-2057-2017 | Labeling Change Control | Indications for use are not cleared or approved for market in the U.S. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171928 (Med-Hot Thermal Imaging, Inc., 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LHQ
Too few LHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LHQ
No recall names LHQ since 2007.
Adverse event reports per year · LHQ
1in 2025
MAUDE reports naming product code LHQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes. The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative…
Read the full statement (110 words)
Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes.
The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage.
Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063047: Medhot Mti 2000 Thermal Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063047
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026